Tag Archives: radiofrequency ablation

Tissue ablation is predominantly cancer therapy

Tissue ablation is defined as the “removal of a body part or the destruction of its function, as by surgery, disease, or a noxious substance.” Put more simply, ablation is considered to be a therapeutic destruction and sealing of tissue.

The technologies representing the majority of physical (rather than chemical) ablation are comprised of the following:

  • Electrical
  • Radiation
  • Light
  • Radiofrequency
  • Ultrasound
  • Cryotherapy
  • Thermal (other than cryotherapy)
  • Microwave
  • Hydromechanical

Source: Report #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities."

The largest share of the market for energy-based ablation devices is used in cancer therapy, primarily using the radiation therapy modality. Following that is general surgery with its use of electrocautery and electrosurgical devices, RF ablation, cryotherapy, etc. Cardiovascular is thought to be third, even though cardiovascular is making the most noise in the medical press with RF and cryoablation of atrial fibrillation, this segment is thought to be third in share order. The remaining applications are relatively small and fall in line behind the three leading sectors.

Growth in the Asia/Pacific Market for Ablation Technologies

 

The Asia-Pacific market for ablation technologies looks quite different from the Americas and European Union. Here, at present, the largest market is Japan, which accounts for the majority of the market, although by population and current growth rates, the People’s Republic of China has the greatest potential. Its greater than 1.3 billion population and, more importantly, the healthcare infrastructure that the government is putting into place ensure that China will continue to comprise an ever greater share of this market.

Asia-pacific-ablation

Data in the exhibit is drawn from MedMarket Diligence report #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities."

 

 

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Shifting caseload and markets in tissue ablation

Technologies to therapeutically ablate tissue (via destruction and/or removal of abnormal tissue or creation of a therapeutic lesion as in blocking errant electrical pathways in arrhythmia) represent a remarkably diverse set of tools despite their fundamentally common capability of tissue ablation.

Spanning electrical, radiation, light/laser, radiofrequency, ultrasound, cryotherapy, thermal therapy, microwave and hydromechanical and embodied in a wide range of medical devices and equipment, all ablation types simply destroy tissue.  The differences lie in respect to the specificity of each modality in targeting disease tissue and in respect to their capacity to be integrated in different types of instruments that may match the demands of specific clinical practices.

The recent history of ablation technology market developments reveals that, despite the specialization of modalities to specific tissues, or the efforts by manufacturers to carve out clinician or disease-state niches for specific modalities, growth in different ablation procedure types and clinical practice patterns has changed steadily but not always predictably.  Recent clinical results, new ablation device innovations and other developments have had the propensity to drive shifts in patient caseload between alternative ablation types.  Given the development and manufacturing costs, have largely and unsurprisingly maintained focus in typically one modality type, seeking to provide innovations in devices and equipment that accentuate benefits for there specific modality in specific clinical applications.

Below is illustrated the worldwide market for ablation technologies in 2009 and forecast 2019.

Source: "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities." Report #A145.

Evolution of ablation technologies and migration of caseload

Technologies to therapeutically ablate tissue (via destruction and/or removal of abnormal tissue or creation of a therapeutic lesion as in blocking errant electrical pathways in arrhythmia) represent a remarkably diverse set of tools despite their fundamentally common capability of tissue ablation.

Spanning electrical, radiation, light/laser, radiofrequency, ultrasound, cryotherapy, thermal therapy, microwave and hydromechanical and embodied in a wide range of medical devices and equipment, all ablation types simply destroy tissue.  The differences lie in respect to the specificity of each modality in targeting disease tissue and in respect to their capacity to be integrated in different types of instruments that may match the demands of specific clinical practices.

The recent history of ablation technology market developments reveals that, despite the specialization of modalities to specific tissues, or the efforts by manufacturers to carve out clinician or disease-state niches for specific modalities, growth in different ablation procedure types and clinical practice patterns has changed steadily but not always predictably.  Recent clinical results, new ablation device innovations and other developments have had the propensity to drive shifts in patient caseload between alternative ablation types.  Given the development and manufacturing costs, have largely and unsurprisingly maintained focus in typically one modality type, seeking to provide innovations in devices and equipment that accentuate benefits for there specific modality in specific clinical applications.

Below is illustrated the worldwide market for ablation technologies in 2009 and forecast 2019.

Source: "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities." Report #A145.

RF Ablation Proving Itself in Barrett’s Esophagus

From PRNewswire and Bio-Medicine.org… link.

Untreated epithelium in Barrett's esophagus

Results presented at this week’s Digestive Disease Week meeting in Chicago illustrated the effectiveness of BÂRRX Medical, Inc.’s HALO ablation system in the treatment of the pre-cancerous condition known as Barrett’s esophagus. The HALO ablation system uses radiofrequency (RF) energy to remove the epithelium in the esophagus of patients with Barrett’s esophagus (see image at right). In addition to these cell’s being pre-cancerous, Barrett’s esophagus is associated with chronic gastroesophageal reflux disease (GERD).

Results from a number of clinical trials were presented during the Digestive Disease Week (DDW) in Chicago this week, revealing new outcomes data related to endoscopic radiofrequency ablation using the HALO ablation system for eradicating a pre-cancerous esophageal condition known as Barrett’s esophagus. Among them, reports included durability outcomes from a randomized sham-controlled trial, safety and efficacy outcomes from a large U.S. registry of 429 patients, a randomized trial comparing ablation to endoscopic resection, and the largest European series to date in patients with high-grade dysplasia and early cancer.

As the DDW meeting commenced, the New England Journal of Medicine published a landmark paper entitled, "Radiofrequency Ablation for Barrett’s Esophagus Containing Dysplasia."  This is a U.S. randomized sham-controlled trial demonstrating high rates of complete eradication of barrett’s and dysplasia in the ablation group as compared to control, as well as a significant reduction in cancer progression.  At DDW, researchers presented new data from this now published trial showing that the ablation effect achieved at 1 year follow-up was highly durable at the 2-year follow-up.  

RF ablation is among a wide-range of energy-based technologies — cryo, microwave, laser, ultrasound, etc. — that are progressively penetrating virtually all clinical specialties where there is a need to selectively, with good clinical control and outcomes, therapeutically remove or ablate tissues.

(See the MedMarket Diligence report #a125, "Worldwide Ablation Technologies, 2008-2017", described at link.)

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Energy-based therapeutics markets by clinical application

Energy-based therapeutics include technologies to effect the destruction or treatment of tissues to remove pathology or otherwise modify tissue (e.g., for creating lesions that block the aberrant signals in arrhythmia).  These technologies include radiofrequency, microwave, laser/light, microwave, cryo, hydromechanical, ultrasound and thermal.

Some sectors of the energy-based market are growing steadily, others more rapidly. RF ablation is seeing lively growth, as are cryotherapy and microwave therapy. Overall, the market is estimated to be increasing at more than 11% per annum, which is significantly higher than growth of the medical device market overall. The buoyancy in the energy-based sector is due partly to increased uptake of these technologies and partly due to introduction of technology refinements, which in turn lead to increased usage. There is also the demographic factor; many of the conditions for which ablation products are used are commoner among older than younger patients, and lengthening life expectancy makes its own contribution to market growth.

Certain clinical sectors demonstrate a more significant share of the ablation market due to the prevalence of diseases and disorders that are amenable to these treatments.  See the current segmentation of the ablation market by clinical application.

energy-by-applicatoins

Source:  MedMarket Diligence report #A125, "Worldwide Ablation Technologies Market."

Cardiovascular applications represent the most significant application, due to the existing caseload and the adoption of ablation technologies, especially in arrhythmia management.  Secondarily, but perhaps with an even greater upside potential, is cancer therapeutics.  

Below see the current distribution of ablation therapy markets across different solid tumor types.

solid-cancers-ablation

Source:  MedMarket Diligence report #A125, "Worldwide Ablation Technologies Market."

 

Ablation technologies market growing rapidly worldwide, particularly in select modalities

The worldwide high energy therapies market represents a $25 billion opportunity in 2008. The category consists of therapeutic devices and equipment that deliver the controlled application of one or more modalities of energy to tissue.

The market will grow at an aggressive rate through 2017 for all modalities, but with some modalities exceeding compound annual growth rate of 20%.  As a result of this, the adoption and growth of energy therapies will exceed the growth of the overall medical device market and the mix of energy therapies will increase.

Below is illustrated the aggregate growth of the ablation therapies market worldwide, by segment, and the relative growth of each of the segments in the market.

ablation-market-total

Note: Total market in  $millions

Source:  MedMarket Diligence Report #A125, "Ablation Technologies Worldwide Market, 2007-2017."

 

Medical technology platforms with high growth potential

Specific technologies and broad technology platforms have tremendous potential for market growth based on combinations of recent technology advancement, changes in clinical practice, current forces in the market and other criterial. 

  • Biotech solutions to traditional medical device technologies.  The thrust of medical technology is, and has been for a long time, to make it as effective as possible while being the least possible invasive.  Taken to the extreme, instead of implanting a device, such as a suture or a staple, the almost perfect solution would to be to close wounds with no device at all.  Hence, surgical sealants, fibrin glues and other medical/surgical adhesives, hemostats and related biologicals (and even non-biologicals like cyanoacrylates), having proven themselves clinically and offering very low adoption hurdles, represent a huge opportunity in the medtech market.
     
  • Ablation and other high energy technologies.  What used to be handled by scalpel when my father did general surgery, is now increasingly being accomplished using energy-driven modalities that provide other tissue effects that a sharp metal blade alone could never do.  These technologies are therefore growing in both the penetration of traditional surgical procedures and their expansion to new clinical applications.
     
  • Nanotech and microelectromechanical systems (MEMS).  It is actually a gross oversimplification to use a word like "nanotech" and imply that you are talking about one type of technology.  The only thing common to nanotech is size; every manner of material, construction, function and clinical benefit is part of this area.  The pace of development is striking.
     
  • Drug-device hybrids.  Just a few of the applications of combining drugs and devices in a single device include localized drug-delivery that avoids toxic, systemic dosages and vastly improved biocompatibility of existing devices. These two options alone represent multiple enormous markets.  Now, naked metal (or other) implants seem almost barbaric.
     
  • Bioresorbable materials.   Polymer and other materials technologies are enabling the development of implants and other devices that conveniently go away when they are no longer needed.  Already a significant market force in areas like bone growth in orthopedics, bioresorbable stents and other implants are proving their worth in cardiology and urology. 
     
  • Atherosclerotic plaque-reversing drugs.  When Pfizer divested itself of Esperion Therapeutics, it did not bode the end of this striking new drug approach to atherosclerosis, it simply illustrated the persistent challenge of drug development.  Here, it should be kept in mind that, the bigger the potential payout, based on huge clinical need (e.g., drug solution to the device intensive treatment of coronary artery disease), the more likely it is only a matter of time before the product reaches the market.  The jury is out on the "when" part, not the "if".
     
  • Rational therapeutics.  This is the holy grail thinking behind the development of many, many biotech products.  If one can develop a cure — a direct resolution of the underlying biological defect or deficiency in disease — and not just the symptoms, then one has changed the market in paradigm ways.  The hurdle and the payoffs are huge.
     
  • Tissue engineering technologies.  We have begun to be able to develop tissue engineered organs of increasing complexity — skin, bladders and rudimentary pancreases — and the benefits of these are in applications too numerous to mention..
     
  • RFID.  There is little, really, that is sophisticated about radiofrequency identification devices,  but their rapid integration into medical technologies of a wide range (tagging surgical instruments so they don’t get left behind, implants that enable external identification or even status, other types) will extend the utility and value of medical devices.
     
  • Noninvasive glucose monitoring.  Optimizing care for diabetes means, at a minimum, very frequent (5-10) checks per day of blood glucose.  This many finger pricks per year by the total number of diabetics globally (a rapidly growing number at that) who clearly would benefit from noninvasive monitoring reveals the value of this opportunity.  Capturing that opportunity means the combined success of both technology and cost.
     
  • Infection control.  This area is a top area, not for the sigificant technologies that have been developed, but the enormous demand for them.  Between rapidly emerging problems like methicillin-resistant staph aureus (MRSA), the resurgence of tuberculosis, the enormous costs of nosocomial infections and other infection-related challenges, infection control is an enormous, global opportunity.
     
  • Spine surgery.   The nature of the human spine, constructed of bone that needs to be both flexible and strong, demands device-intensive solutions.  The growing patient population of active, older adults is ratcheting the pressure on technologies to be less invasive, provide greater range of motion, last longer, cost less — all of which drives innovation in spine surgical technologies.
     
  • Obesity treatment technologies.  Technology solutions to the increasingly prevalant problem of obesity are imperfect, but still are frequently better solutions for the obese than an alternative that may ultimately also encompass heart disease, diabetes, stroke and other problems.  Diverse drug and device alternatives have been developed and the trend in obesity incidence will simply drive their continued development. 

Other forces are at work driving the above technologieis including, of course, cost containment, the integration of information technologies in both medical product and development process and the globalized economy.

(While the above list  is separately a White Paper that I have written, and periodically re-write to reflect new stuff being developed, I find it interesting and worthwhile to revisit frequently and discuss in this blog.)


The above topics are covered in various MedMarket Diligence reports.  See our list of titles.

 

 

 

Energy modalities and market growth in ablation technology

The global market for medical devices is currently a $185 billion opportunity and at least 13% of this market involves products that provide the controlled application of energy to tissue. The segment is dominated by high technology products ranging from devices that can heat and cool tissue over a 600° C temperature range of -200° C to +400° C to those that can vibrate at fifty five thousand cycles per second to denature tissue. While a significant share of the energy-based therapies market is for elective procedures such as refractive eye surgery and cosmetic hair removal, treatments for chronic diseases make up the vast majority of the applications of these technologies.

Underlying the growth of this market will be changes in demographics. The baby boomer generation–those born between 1946 and 1964–represents about one-third of the population in economically-developed countries. Many of these ageing citizens have both the economic means and the demand for therapies that can extend their active lives and delay the visible signs of aging.

Pushing the growth of energy therapies beyond basic changes in demographics are the unique benefits that they offer. They are typically less invasive than traditional surgery and are generally employed without the need for an implant. The therapies can be precisely metered and can be repeated. Emerging energy modalities have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve.

Ultrasonic energy offers superior control of energy output. 3D control and directionality of the energy delivered provides the ability to treat a prescribed target volume and shape which is critical for tumor ablation as increased energy penetration into the target tissue enables the treatment of larger tumor volumes and reduces treatment times. Peripheral and coronary vascular occlusive conditions that afflict tens of millions of people worldwide are now being treated with technologies that enable the delivery of ultrasonic energy over the active length of a small diameter guidewire-like device in an occluded blood vessel. The popularity of ultrasonic surgical systems is being driven by their inherent advantages. These systems control bleeding by coaptive coagulation at low temperatures ranging from 50ºC to 100ºC. Coagulation occurs by means of protein denaturation as opposed to thermal welding and the absence of smoke improves the visual field.

Cryogenic energy or the extreme absence of heat is very attractive as it is highly containable and thus localized. Cryoablation can be safely employed adjacent to delicate tissue and structures such as certain vasculature. Cryoablation may eliminate many of the problems seen in treating complex arrhythmias such as pulmonary vein stenosis. Cooling freezes tissue and does not seem to cause extracellular matrix changes or damage to the endocardium, which may lower clot-related complications. Thanks largely to advances in ultrasound, which allows physicians to target diseased tissue with pinpoint accuracy, and temperature control, which allows physicians to destroy the diseased tissue without harming the surrounding healthy tissue, cryoablation has become the fastest growing minimally invasive option for prostate cancer patients.

Microwave energy offers the inherent advantage of accommodating parallel delivery points. An increased treatment area can be treated with microwave energy very efficiently. Microwave probes are ideally suited for a full spectrum of cardiac ablation procedure from simple pulmonary vein isolation in paroxysmal AF to a full Maze for permanent AF. Energy delivery times are short, on the order of 25 to 60 seconds, and the unidirectionality of the microwave ensures the protection of surrounding tissues during epicardial application–a significant requirement for beating-heart application. Microwave energy is also being used as a transurethral therapy to treat BPH.

Light energy is being harnessed and focused for a variety of therapeutic applications. CO2 lasers are being used to revascularize injured myocardial tissue while excimer lasers are being adapted to atherectomy catheters that can clear thrombosis and reperfuse vessels. Over 2 million individuals seek the therapeutic benefits of laser vision correction each year; low level “cold” lasers are being employed to treat chronic pain relief for debilitating conditions like carpal tunnel syndrome–a leading cause of lost workdays. Intense pulsed light (IPL) that affects subtle changes in collagen is being used to treat vascular and pigmentation irregularities.

Hydromechanical energy systems that jet streams of saline only five one-thousandths of an inch in diameter — about the thickness of a human hair–can precisely dissect tissue, sparing vessels and nerves, and are being employed for hepatic resection and nerve-sparing retropubic radical prostatectomy. This modality does not cause thermal damage to tissue and can sculpt, ablate and cauterize bleeders.

Radiation energy using focused arrays of intersecting beams of gamma radiation is being used to treat lesions within the brain. Radiosurgery devices that can ablate otherwise untreatable tumors and malformations when directed by computers are finding otherwise untreatable lesions.

Thermal energy is employed successfully to treat menorrhagia due to benign causes in premenopausal women. When tissue is heated above 46°C, cellular protein denatures and the cell dies. Thermal uterine balloon therapy offers a less-invasive option that allows women to preserve their uterus. Thermal therapy is also being employed for breast and prostate cancer. Implants made of ferromagnetic material that can be “turned-on” when placed within an electromagnetic field and heated in situ offer a high degree of specificity with respect to the treated tissue area.

Electrical energy delivered by small implants can deliver a life saving jolt of electricity to shock a patient’s heart back to normal when rhythmic disturbances of the lower heart chambers that can cause sudden cardiac death are detected. Similar devices deliver electrical energy to speed up a heart beating too slowly. Image-guided radiofrequency ablation which uses heat to destroy diseased tissue can preserve kidney function and avoid kidney dialysis for patients with solid renal tumors who are not surgical candidates.

Radiofrequency energy is gaining widespread use in the field of sports medicine surgery for the thermal modification of soft tissue structures within the joint. The use of radiofrequency energy for thermal chondroplasty has gained tremendous popularity because of the quality of the therapy. Radiofrequency surgical systems have the inherent ability to seal large vessels as a result of the tremendous temperatures the energy can generate.

Given the varying clinical utilities of the different energy modalities and the correspondingly different current and potential caseload, the growth in the market for ablation technologies varies by modality, as shown below.

ablation-modality-growth

 Source:  MedMarket Diligence, LLC; "Ablation Technologies Worldwide Market, 2008-2017." Report #A125.

Leaders in markets for ablation and other energy-based technologies

Medtronic is the predominant player in the energy-based therapies market. With global sales of nearly $4.9 billion attributable to energy-based products, it controls over half of the cardiac rhythm market and almost a quarter of all energy-based product sales. Boston Scientific, also focusing on cardiac arrhythmias, comes next in the revenues table with a $2. 9 billion share. St. Jude Medical, the joint number three player enjoys sales of nearly $2 billion for energy therapies such as implantable defribrillators and pacemakers using electrical energy to restore normal heart rhythm . Varian Medical shares the number three spot with almost $2 million in sales. Varian is the world’s leading manufacturer of integrated cancer therapy systems and markets a full line of linear accelerators for radiation therapy.

With sales of over $800 million for energy-based products, Biosense Webster, a Johnson & Johnson company, comes next in market share. Then comes Covidien (formerly Tyco Healthcare) with its member company Valleylab specialising in devices for electrosurgery and vessel sealing. Smith & Nephew generates sales of $600 million from energy-based therapies including devices for radiofrequency and hydro-ablation. The remaining three companies in the "top ten" each generate annual revenues in the $200-300 million range from energy-based devices; they are Arthrocare, Getinge and Olympus.

 

Market Leaders in Energy-Based Therapies

Company

Product Area

Main indication

AngioDynamics

RF

Lung cancer

Arthrocare

RF

Nucleoplasty

Atricure

RF

Atrial arrhythmias

ATS

Cryogenic

Cardiac arrhythmias

Biosense Webster (J&J)

RF

Atrial arrhythmias

Boston Scientific

RF

Atrial arrhythmias

Candela

Light

Hair removal

CardioGenesis

Light

Angina pectoris

Covidien

RF, Microwave, Ultrasound

Soft tissue ablation

EDAP TMS

Ultrasound

Prostate cancer

Endocare

Cryogenic

Prostate cancer

HealthTronics

Light

BPH

Maquette (Getinge)

RF

Hepatic cancer

Medtronic

Electrical

Tachyarrhythmia

Olympus

RF

Gynaecology, ENT, soft tissue ablation

Smith & Nephew

RF, Hydro

Soft tissue ablation, Capsular shrinkage

St Jude

Electrical

Cardiac arrhythmias

TheraGenics

Radiation

Prostate cancer

Varian

Radiation

Cancer

VNUS

RF

Saphenous vein closure

Source: MedMarket Diligence, LLC


The above is an excerpt from report #A125, "Ablation Technologies Worldwide Market, 2008," published September 2008.